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Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Trigonella Foenum-graecum Seed Extract

Drug: Placebo

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

The level of ALT and AST greater than 1.5 and less than 10 times normal level
Ultrasound evidence confirm fatty liver disease; age between 18-70 years old
Negative pregnancy test for women in reproductive age (up to two weeks prior to the study)
Negative for hepatitis B and C
BMI: 18.5 to 40
Sign the consent form.

Exclusion criteria:

History of more than one unit of alcohol consumption (one value for the Spirits (vodka; whiskey)
Wine and Beer are respectively 30-45 cc; 120-150 cc and 360 cc.)
Fatty liver controller medications
Glucose lowering drugs
Cholesterol lowering drugs
Hypotensive drugs
Consumption of vitamin E
Taking coenzyme Q10
Administration of corticosteroids & glucocorticoids
Thyroxin administration
Administration of drugs that cause fatty liver
Diabetes (type 1 and 2)
History of cancer in the past
Hepatocellular carcinoma
Renal failure (creatinine> 1.5 x ULN)
Chronic pancreatitis
Cirrhosis
Uncontrolled hypertension (above 180 mm Hg systolic blood pressure); heart disease
Autoimmune hepatitis
Primary biliary cirrhosis
Primary sclerosing cholangitis (alkaline phosphatase levels greater than 3 times normal)
Wilson's disease
Alpha-1 antitrypsin deficiency and coronary artery disease
Symptoms of hypothyroidism
Hyperthyroidism
Disorders of the hypothalamic - pituitary
Liver transplantation
Pregnant or lactating women
Those who cannot use contraceptives.

Sites / Locations

Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Drug: Trigonella Foenum-graecum

Drug: Placebo

Arm Description

in this group patients use Trigonella Foenum-graecum seed extract twice daily.

in this group patients use placebo twice daily.

Outcomes

Primary Outcome Measures

Liver stiffness change

Assessment by Fibroscan

Secondary Outcome Measures

Full Information

NCT ID

NCT02303314

First Posted

November 21, 2014

Last Updated

September 21, 2017

Sponsor

Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02303314

Brief Title

Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Two group use capsules which contain TFG or placebo, respectively.

Detailed Description

This study design to examine performance of trigonella foenum-graecum in treatment of non-alcoholic fatty liver disease. Patients 18-70 year old with the levels of ALT and AST greater than 1.5 and less than 10 times normal level, and ultrasound evidence confirm fatty liver disease include in study. Patients with alcohol consumption, other liver disease and taking medications that cause liver injury, exclude. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Control group, in addition to diet and exercise recommendations take placebo capsules for 3 months. Intervention group, in addition to diet and exercise recommendations, use capsules containing hydro-alcoholic extract of fenugreek 1g/d for 3 months. At baseline and 6 and 12 weeks after intervention, the investigators measure FBS, insulin, insulin resistance, Albumin, Aspartate transaminase, Alanine Aminotransferase, Alkaline phosphatase, Total bilirubin, Direct bilirubin, HbA1c, total cholesterol, LDL, HDL, TG, High sensitivity C reactive protein and Creatinine. At baseline and 12 weeks after intervention fibroscan perform to evaluate the amount of fat in liver. In order to decrease bias, patient, physician who performs fibroscan and the person analyzing the data are blind to group drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug: Trigonella Foenum-graecum

Arm Type

Other

Arm Description

in this group patients use Trigonella Foenum-graecum seed extract twice daily.

Arm Title

Drug: Placebo

Arm Type

Other

Arm Description

in this group patients use placebo twice daily.

Intervention Type

Drug

Intervention Name(s)

Trigonella Foenum-graecum Seed Extract

Intervention Type

Drug

Intervention Name(s)

Drug: Placebo

Primary Outcome Measure Information:

Title

Liver stiffness change

Description

Assessment by Fibroscan

Time Frame

At baseline and 12 weeks after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: The level of ALT and AST greater than 1.5 and less than 10 times normal level Ultrasound evidence confirm fatty liver disease; age between 18-70 years old Negative pregnancy test for women in reproductive age (up to two weeks prior to the study) Negative for hepatitis B and C BMI: 18.5 to 40 Sign the consent form. Exclusion criteria: History of more than one unit of alcohol consumption (one value for the Spirits (vodka; whiskey) Wine and Beer are respectively 30-45 cc; 120-150 cc and 360 cc.) Fatty liver controller medications Glucose lowering drugs Cholesterol lowering drugs Hypotensive drugs Consumption of vitamin E Taking coenzyme Q10 Administration of corticosteroids & glucocorticoids Thyroxin administration Administration of drugs that cause fatty liver Diabetes (type 1 and 2) History of cancer in the past Hepatocellular carcinoma Renal failure (creatinine> 1.5 x ULN) Chronic pancreatitis Cirrhosis Uncontrolled hypertension (above 180 mm Hg systolic blood pressure); heart disease Autoimmune hepatitis Primary biliary cirrhosis Primary sclerosing cholangitis (alkaline phosphatase levels greater than 3 times normal) Wilson's disease Alpha-1 antitrypsin deficiency and coronary artery disease Symptoms of hypothyroidism Hyperthyroidism Disorders of the hypothalamic - pituitary Liver transplantation Pregnant or lactating women Those who cannot use contraceptives.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seyed Alireza Taghavi

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shiraz University of Medical Sciences

City

Shiraz

State/Province

Fars

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease

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